Guest Column | October 30, 2026

Closing The CAR-T Access Gap With Hospital-Based Manufacturing

Boro Dropulić, Ph.D., MBA, Caring Cross

empty hospital beds, clean clinical environment-GettyImages-2267391736

CAR T cell therapy is a rapidly growing treatment modality in oncology.1,2 A single infusion of a patient's own engineered T cells can induce lasting remission of a leukemia or lymphoma that has resisted every other treatment. Cellular gene therapies are also platform medicines: once a manufacturing process and vector system are established, new products can be created by engineering the genetic construct rather than discovering a new molecule.

That promise is constrained by limited patient access, driven by high prices and centralized manufacturing and distribution.1 U.S. list prices for approved autologous CAR T products ranged from $462,000 to $594,000 in 2025.2 In a SEER-Medicare analysis, only 5.4% of patients with relapsed or refractory diffuse large B-cell lymphoma receiving third-line or later therapy were treated with CAR T,3 and in Europe only about two in 10 eligible patients with large B-cell lymphoma are treated.4

This is part 1 of a series on improving access to CAR T cell therapy through distributed manufacturing. Part 2 explores technical and regulatory considerations of standing up a hospital-based network.

Point-of-care (POC) manufacturing, defined as production within or adjacent to the treating hospital under a licensed quality system, offers an alternative. It aims to extend access to patients who do not receive these therapies today and to achieve regulatory approval of products manufactured at or close to hospitals.

Barriers To Access Extend Beyond Price

The principal value of POC manufacturing is clinical: it removes barriers that prevent eligible patients from being treated at all (Table 1).

Table 1. Barriers to CAR T access and supporting evidence

Barrier Published evidence Relevance of POC manufacturing
Vein-to-vein delay Median 30.6 - 48.4 days for commercial products; ≥40 vs. <28 days associated with worse overall survival (HR 1.33)5 On-site production allows better patient scheduling and fresh or frozen infusion of the CAR T cell product, depending on patient need
Manufacturing slot scarcity Only 60% of wait-listed myeloma patients obtained a slot; mortality without CAR T was 81%;6 a 17-center survey reported a median 25% death rate while waiting7 Capacity scales with the number of treating hospitals
Geographic distance On average, patients live 59.7 miles from the nearest academic center; 42% of patients below the poverty line live ≥50 miles away;8 each additional 10 miles lowers the likelihood of receiving CAR T by 6.2%3 Manufacturing capability in regional hospitals
No local supply in low- and middle-income countries (LMICs) India approved its first domestically manufactured CAR T only in 20239,10 Domestic production at local cost

Clinical Evidence From Point-Of-Care Manufacturing Sites

Prospective studies show that hospital-manufactured products achieve efficacy and safety comparable to commercial products (Table 2).

Table 2. Selected prospective studies of hospital-manufactured or domestically manufactured CD19- or CD19/CD20-directed CAR T

Study Setting Manufacturing or vein-to-vein time Efficacy Grade ≥3 CRS / ICANS
CART19-BE-01, ARI-000111,12 Spain, 47 7- to 10-day production 84.2% MRD-negative CR (ALL) 13.2% / 2.6% (ALL)
CART19-BE-02, varnimcabtagene13 Spain, adult ALL, 32 — 84.4% MRD-negative CR 12% / one case
LV20.19 tandem CAR14 U.S., 22 14-day on-site manufacturing; 68% fresh infusion ORR 82%, CR 64% 5% / 14%
CLIC-0115 Canada, 30 Median 15 days from apheresis to infusion ORR 76.7% 6.7% / 3.3%
Sheba16 Israel, 73 Median 10-day manufacturing ORR 62.5%, CR 37.5% (LBCL) 9.5% / 21.9%
HD-CAR-117 Germany, 15 Median 10-day manufacturing CR 77% (ALL) 0% / 0%
NexCAR1910 India, domestic manufacture, multicenter, 64 Median 10-day manufacturing Phase 2 ORR 73% 5% (2/37) / 0%18
VELCART19 India, 10 9-day vein-to-vein 6/6 MRD-negative (B-ALL) 10% (1/10) / 0%

Definitions: ALL, acute lymphoblastic leukemia; CR, complete response; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; LBCL, large B-cell lymphoma; MRD, measurable residual disease; ORR, overall response rate.

Response and toxicity rates in these studies fall within the range reported in the registration trials of commercial products,20,21 although cross-trial comparison is limited by differences in populations and constructs. Hospital manufacture has also proved reliable: after process optimization, CLIC-01 reported a 100% manufacturing success rate across 29 runs, and every infused participant received the target dose.15 Short, automated processes have repeatedly achieved vein-to-vein intervals of nine to 15 days,15,19,22 against the 30 to 48 days typical of commercial supply.5 On-site manufacture also removes the shipping, slot-allocation, and scheduling delays that a shorter process alone cannot.

Cost Of Goods, Labor, And Vector Supply

A European academic analysis estimated a cost of less than $68,000 per product at 18 products a year, against commercial prices of up to $363,000.23 In a separate analysis, ARI-0001 was reimbursed by the Spanish national health system at $101,000, about one-third of the price of commercial CAR T.12,24 Hospital production costs and reimbursement prices are thus a fraction of commercial list prices, even before the savings from lower labor and vector costs described below.

A process-economics model identified two main drivers of cost: purchase of the lentiviral vector and labor-intensive quality control (QC) release testing.25 Ongoing efforts to automate and streamline QC testing are expected to reduce this cost.26 Because labor is a major component of cost, production costs are substantially lower where a skilled scientific workforce is available at lower wage levels, as in many countries outside the United States and Europe. In India, a detailed cost analysis of POC manufacture on a closed automated platform reported a production cost of about $35,000 per product excluding vector.19,27

A key consideration is that each hospital must release every product, which adds staff, instruments, and documentation at every site. Three developments mitigate this.

First, quality-system models for decentralized manufacturing run a unified network quality system alongside each hospital's own quality system, which streamlines production and centralizes product release. Regulatory oversight sits with a reference site, which runs verification batches before new sites are qualified.28 This mirrors how companies already manufacture commercial CAR T products. Kite, for example, produces its CAR T therapies at FDA-licensed facilities in Southern California and Frederick, Maryland, and at a European site near Amsterdam, operating them as a single manufacturing network.29,30

Second, closed-system platforms have been shown to produce products with consistent characteristics across sites. Two German centers using the same closed system to manufacture a CD20-directed CAR T reported CAR-positive fractions of 34% to 61% and T-cell purity above 98.5%.31 Similarly, CD19-directed CAR T cells manufactured with identical devices, materials, and reagents in Cleveland, Ohio, and Moscow, Russia, and infused fresh in almost all patients, showed comparable transduction efficiency (median 48% and 60%, respectively) and cellular composition (more than 90% CD3+ cells) on multiparameter flow cytometry at both sites, and induced high remission rates in both pediatric leukemia and adult lymphoma.32 The application of artificial intelligence (AI) to the review of deviation reports and process data, and in support of real-time release testing, will likely further reduce the release burden in the future.33

Third, release testing is becoming more efficient: nucleic acid amplification methods for mycoplasma detection return results in under five hours, compared with 28 days for the reference culture method.26 Rapid real-time PCR sterility assays are also available, such as Sartorius' Microsart ATMP Sterile Release and Thermo Fisher's SteriSEQ; they detect bacterial and fungal contaminants within hours (about three hours for Microsart), so a sterility result is available before infusion while the 14-day compendial culture test runs in parallel.34,35

Potency and vector copy number assays are also becoming faster and less costly: flow cytometry-based potency assays that require no specialized equipment have been validated for routine batch release,36 and digital polymerase chain reaction (PCR), including droplet-based formats, measures vector copy number without a standard curve, with less variability and fewer manual steps than quantitative PCR.37 These assays are therefore less of a release bottleneck than they once were.

Lentiviral vectors are currently the preferred gene-delivery vehicle for CAR T manufacture, which makes vector a critical and costly material. Material costs of about $35,000 per product have been reported when vector is supplied by a sponsor or collaborator, but costs rise substantially, to $50,000 or more, when a center must purchase GMP-grade vector commercially.22 Improved lentiviral vector manufacturing methods can decrease the cost of vector by at least 90%.38 As such process improvements reach commercial supply, lentiviral vector prices are falling: prices as low as about $10,000 per dose have been reported for nonbranded anti-CD19 CAR vectors,39 and simplified modular cell manufacturing processes can keep other material costs at a similar level. At these costs, regional manufacturing of CAR T products for local hospital networks becomes economically feasible. Simplified workflows can, for example, isolate T cells directly from whole blood with a soluble antibody-based negative-selection reagent, avoiding magnetic column separation, and expand them in gas-permeable culture vessels.40 Using whole blood rather than an apheresis product as the starting material is particularly advantageous in low-income countries, where apheresis facilities are scarce and the procedure adds substantially to production costs.41

The Evidence Supports Hospital-Based Manufacturing

Hospital-manufactured CAR T products match commercial products on efficacy and safety. Their short on-site processes can reduce vein-to-vein time by several weeks, which is critical for patients with advanced disease. The shorter turnaround time may also enable treatment of more severely ill patients while reducing the need for prolonged, burdensome bridging therapies. Beyond logistics, improvements in vector cost, closed-system processing, and new advances for more efficient QC testing will help to bring down manufacturing costs enough to make the proximity gains attractive. The harder question is how hospitals can reliably stand up their own manufacturing suites. Part 2 of this series examines facility utilization, regulatory pathways, and the role of local manufacturing in national resilience.

Editor's note: The author discloses that he is executive director of Caring Cross and chief executive officer of Vector BioMed.

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About the Author:

Boro Dropulić is executive director of Caring Cross, a nonprofit organization focused on access to advanced therapies in the public health sector, and chief executive officer of Vector BioMed, a public benefit corporation and viral vector manufacturer that enables companies to deploy CAR-T cell and other advanced therapies in their regions. Reach him at boro.dropulic@caringcross.org.